This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.

A Pilot, Phase II, Open-label, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GW640385 When Administered With Ritonavir in Combination With NRTIs for 48 Weeks in HIV-1 Infected Adults

Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure. [ Time Frame: throughout the study ]

Enrollment:

30

Study Start Date:

October 2004

Study Completion Date:

January 2007

Primary Completion Date:

January 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: GW640385
Drug: Ritonavir

Other Names:

Ritonavir

GW640385

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria:

HIV-1 infected subjects.

Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.

Plasma HIV-1 RNA (viral load) >/=1,000 copies/mL at Screening.

CD4+ cell count >/= 200 cells/mm3 at Screening.

Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen.

Willing and able to provide signed and dated written informed consent prior to study entry.

Exclusion criteria:

Active CDC Class C disease.

Pregnant or breastfeeding women.

Protocol-specified laboratory abnormalities at Screening.

Personal or family history of autoimmune disease.

History or current indication of thyroid dysfunction or current thyroid gland abnormalities.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257621